DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Applicant's arguments, filed 02/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-2, 4, 10-11, 13-15, and 17-18.
Applicants have left claims 3, 5-9, 12, 16, and 19-21 as originally filed/previously presented.
Claims 1-21 are the current claims hereby under examination.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 9 of Remarks, filed 02/23/2026, with respect to claims 11, 14, 15, 17, and 18 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 11, 14, 15, 17, and 18 have been withdrawn.
Claim Interpretation - 35 USC § 112(f) - Maintained
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 10: The claim limitation “sweat attraction mechanism configured to continuously draw sweat from the sweat chamber into the loading chamber” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “mechanism” coupled with functional language “configured to continuously draw sweat from the sweat chamber into the loading chamber” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “mechanism”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“sweat collection paper … material capable of attracting and absorbing a quantity of sweat … can be porous to enhance the liquid attraction capability …”), or equivalents thereof, as described in para. [0027] and para. [0051] of the disclosure filed on 06/09/2023.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 9-11 of Remarks, filed 02/23/2026, that “claim 10 has been amended to state “sweat attraction mechanism” … recite sufficient structure to perform the claimed function …”.
The Examiner respectfully disagrees. As reiterated above, the claim recites a generic placeholder “mechanism”, coupled with functional language “configured to continuously draw sweat from the sweat chamber into the loading chamber”. The generic placeholder is not modified by sufficient structure to perform the claimed function, and the specification must be relied upon to determine the structure. Therefore, 112(f) interpretation is correct. Unlike “detent mechanism”, as cited by the Applicants, which provided sufficient and art-recognized structure for “mechanism”, the Applicants have not shown that “sweat attraction” or “sweat attraction mechanism” is a well-known, art-recognized structure to perform the claimed function. The specification must be relied upon to determine the structure.
Claim Rejections - 35 USC § 101 - Withdrawn
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Response to Arguments
Applicant’s arguments, see page 11 of Remarks, filed 02/23/2026, with respect to the 101 rejection of claim 4 have been fully considered and are persuasive. Applicants have amended the claim, rendering the rejection moot. The 101 rejection of claim 4 has been withdrawn.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (US 20180289296 A1) (previously cited), hereinafter referred to as Heikenfeld, in view of Zevenbergen et al. (US 20140012114 A1) (previously cited), hereinafter referred to as Zevenbergen, in view of Peyser et al. (US 20070027383 A1), hereinafter referred to as Peyser.
The claims are generally directed towards a wearable device comprising: a sweat collection unit comprising: at least one microfluidics channel with hydrophilic surfaces configured to collect sweat from skin of a user, a chamber configured to hold the sweat, and a loading chamber comprising disposable sweat collection paper, wherein the disposable sweat collection paper is configured to attract the sweat so the chamber is continuously filling with fresh sweat; and a chloride sensing unit located within the chamber comprising a gold working electrode and a counter electrode, wherein the gold working electrode and the counter electrode are configured to: determine whether the sweat is within the chamber, and in response to a determination that the sweat is within the chamber, deliver a voltage waveform that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, wherein signals reflecting the electrochemical reaction between the chloride ions and the gold molecules are transmitted to an external device, and wherein the wearable device is flexible.
Regarding claim 1, Heikenfeld discloses a wearable device (Abstract, “fluid sensing device …”, para. [0042], “wearables”) comprising:
a sweat collection unit (Fig. 10, element 1032, para. [0060], “sweat collector”) comprising:
at least one microfluidics channel with hydrophilic surfaces configured to collect sweat from skin of a user (Fig. 10, element 1032, para. [0060], “sweat collector … a network of hydrophilic microchannels … sweat is moved along sweat collector …),
a chamber configured to hold the sweat (Fig. 10, element 1032, para. [0060], “sweat collector … a network of hydrophilic microchannels …” - The sweat collector includes a plurality of microchannels, that holds sweat. The “chamber” being a portion of the plurality of microchannels that are in contact with elements 1026, 1020, 1022, 1024, and 1028), and
a loading chamber comprising disposable sweat collection paper, wherein the disposable sweat collection paper is configured to attract the sweat so the chamber is continuously filling with fresh sweat (Fig. 10, element 1030, “fluid sample pump”, para. [0046], “fluid sample pump … textile, paper, or hydrogel, and that serves to maintain fluid flow through the device …”, para. [0049], para. [0060]); and
a chloride sensing unit located within the chamber comprising a working electrode and a counter electrode (Fig. 10, element 1026, element 1028, para. [0083], “chloride sensors …”), wherein the working electrode and the counter electrode are configured to:
wherein signals are transmitted to an external device (Fig. 1, para. [0044], “device is in wired communication or wireless communication with a reader device …”), and
wherein the wearable device is flexible (Fig. 10, element 1070, para. [0045], “flexible electronics …”).
However, Heikenfeld does not explicitly disclose the chloride sensing unit comprises a gold working electrode, and the gold working electrode and the counter electrode are configured to: deliver a voltage waveform that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, and signals reflecting the electrochemical reaction between the chloride ions and the gold molecules are transmitted.
Zevenbergen teaches an analogous wearable device (Abstract, Fig. 1, para. [0045]). Zevenbergen further teaches a chloride sensing unit comprises a gold working electrode configured to deliver a voltage waveform that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, and signals reflecting the electrochemical reaction between the chloride ions and the gold molecules are transmitted (para. [0042], “data transmission circuitry …”, para. [0043-0044], “detect a concentration of chloride ions in sweat … voltage different between the two electrodes …”, para. [0051-0052], para. [0060], “first electrodes … gold”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device and chloride sensing unit disclosed by Heikenfeld to additionally comprise a gold working electrode configured to deliver a voltage waveform that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, and signals reflecting the electrochemical reaction between the chloride ions and the gold molecules are transmitted, as taught by Zevenbergen. This is because Zevenbergen teaches the detection of chloride concentration can be performed using an electrochemical reaction caused by an application of voltage (para. [0043-0044]), gold electrodes are suitable for use in electrochemistry (para. [0060]) yielding predictable results, and transmitting chloride concentrations allow for monitoring of medical conditions (para. [0030]).
However, modified Heikenfeld does not explicitly disclose the electrodes are configured to determine whether the sweat is within the chamber, and in response to a determination that sweat is within the chamber, deliver a voltage waveform.
Peyser teaches an analogous wearable device for collecting sweat (Abstract, para. [0015]). Peyser further teaches determining whether sweat is within a chamber, and in response to a determination that sweat is within the chamber, deliver a voltage waveform (para. [0103], para. [0123-0125], para. [0130-0132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chloride sensing unit to additionally determine whether the sweat is within the chamber, and in response to a determination that the sweat is within the chamber, deliver a voltage waveform, as taught by Peyser. This is because Peyser teaches that determining if sweat is within the chamber and delivering a voltage waveform in response to a determination allows for an appropriate amount of sweat to be collected in order to make proper determinations (para. [0130-0132]).
Regarding claim 2, modified Heikenfeld discloses the wearable device of claim 1, further comprising a drug delivery unit comprising a drug configured to trigger a release of sweat, wherein the drug is released from the drug delivery unit to trigger the release of sweat via iontophoresis (Fig. 13A, para. [0029], “sweat stimulation … drugs using iontophoresis …”, para. [0071], “sweat stimulation … iontophoresis capabilities … electrode, and component is an agar gel with pilocarpine …”).
However, modified Heikenfeld does not explicitly disclose the drug is released in response to a determination by a processor that the sweat is not within the chamber.
Peyser further teaches the drug is released in response to a determination by a processor that the sweat is not within the chamber (para. [0057], para. [0097], para. [0103], para. [0123-0125], para. [0129-0132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by modified Heikenfeld to additionally release the drug in response to a determination by a processor that the sweat is not within the chamber, as taught by Peyser. This is because Peyser teaches releasing a drug in response to determination of not an appropriate amount of sweat allows for sweat to be induced to obtain a large enough sample to obtain accurate results (para. [0129-0132]).
Regarding claim 3, modified Heikenfeld discloses the wearable device of claim 2, wherein the drug delivery unit comprises a positive electrode configured to undergo electrophoresis to release the drug and a collection unit comprises a negative electrode to collect the drug (Fig. 13A, Fig. 13B, Fig. 13C, para. [0029], “positive pole … negative pole …”, para. [0072], “plurality components for sweat stimulation …”, para. [0074], “control, initiate, or stop flow of sweat …”).
Regarding claim 4, modified Heikenfeld discloses the wearable device of claim 2, wherein the released drug is configured to be collected from a body of the user via iontophoresis (Fig. 13A, Fig. 13B, Fig. 13C, para. [0029], “positive pole … negative pole …”, para. [0072], “plurality components for sweat stimulation …”, para. [0074], “control, initiate, or stop flow of sweat …”).
Regarding claim 8, modified Heikenfeld discloses the wearable device of claim 1.
However, modified Heikenfeld does not explicitly disclose wherein the gold working electrode is a circular working electrode and the counter electrode is a semi-circular counter electrode.
Zevenbergen further teaches the gold working electrode is a circular working electrode and the counter electrode is a semi-circular counter electrode (para. [0060-0061], para. [0115]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes taught by modified Heikenfeld to explicitly have the gold working electrode as a circular working electrode and the counter electrode as a semi-circular counter electrode, as taught by Zevenbergen. This is because Zevenbergen teaches numerous different shapes of electrodes can be chosen, as long as the electrodes do not form sidewalls (para. [0060-0061]).
Regarding claim 9, modified Heikenfeld discloses the wearable device of claim 1, wherein the counter electrode comprises gold, silver chloride, and/or platinum (para. [0083]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (US 20180289296 A1) (previously cited), hereinafter referred to as Heikenfeld, in view of Zevenbergen et al. (US 20140012114 A1) (previously cited), hereinafter referred to as Zevenbergen, in view of Peyser et al. (US 20070027383 A1), hereinafter referred to as Peyser as applied to claim 1 above, and further in view of Javey et al. (US 20230157587 A1) (previously cited), hereinafter referred to as Javey.
Regarding claim 7, modified Heikenfeld discloses the wearable device of claim 1.
However, modified Heikenfeld does not explicitly disclose wherein impedance is measured between the gold working electrode and the counter electrode to determine whether the sweat is within the chamber.
Javey teaches an analogous wearable device (Abstract, Fig. 1) comprising a sweat collection unit (Fig. 1, para. [0111]) and a sensing unit (Fig. 1, para. [0129-0132]). Javey further teaches impedance is measured between the gold working electrode and the counter electrode to determine whether the sweat is within the chamber (para. [0080], para. [0112-0113], para. [0129-0130]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device taught by modified Heikenfeld to additionally use impedance measured between the gold working electrode and the counter electrode to determine whether the sweat is within the chamber, as taught by Javey. This is because Javey teaches a change in impedance is a reliable indicator for a hydration level between two electrodes (para. [0129]).
Claims 10-12, 15-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (US 20180289296 A1) (previously cited), hereinafter referred to as Heikenfeld, in view of Zevenbergen et al. (US 20140012114 A1) (previously cited), hereinafter referred to as Zevenbergen, in view of Peyser et al. (US 20070027383 A1), hereinafter referred to as Peyser, in view of Javey et al. (US 20230157587 A1) (previously cited), hereinafter referred to as Javey.
Regarding claim 10, Heikenfeld discloses a system (Abstract, “fluid sensing device …”) comprising:
a sweat sensing and collection unit (Fig. 10, element 1000, para. [0060]) comprising:
at least one inlet having microfluidic properties and configured to collect sweat when positioned on skin of a user by negative capillary pressure attracting the sweat from the skin (Fig. 10, element 1032, para. [0060], “sweat collector … a network of hydrophilic microchannels … sweat is moved along sweat collector …),
a sweat chamber configured to hold a volume of the sweat (Fig. 10, element 1032, para. [0060], “sweat collector … a network of hydrophilic microchannels …” - The “sweat chamber” being a portion of the plurality of microchannels that are in contact with elements 1026, 1020, 1022, 1024, and 1028) and comprising:
a working electrode (Fig. 10, element 1026, element 1028, para. [0083], “chloride sensors …”), and
a counter electrode (Fig. 10, element 1026, element 1028, para. [0083], “chloride sensors …”),
a loading chamber in fluid communication with the sweat chamber and configured to hold at least a portion of the volume of sweat, wherein the loading chamber includes a sweat attraction mechanism configured to continuously draw sweat from the sweat chamber into the loading chamber (Fig. 10, element 1030, “fluid sample pump”, para. [0046], “fluid sample pump … textile, paper, or hydrogel, and that serves to maintain fluid flow through the device …”, para. [0049], para. [0060]); and
at least one microchannel in fluid communication with the at least one inlet, the sweat chamber, and the loading chamber and configured to use negative capillary pressure to move sweat from the at least one inlet to the sweat chamber and to the loading chamber (Fig. 10, element 1032, para. [0060], “sweat collector … a network of hydrophilic microchannels … sweat is moved along sweat collector …).
However, Heikenfeld does not explicitly disclose a controller configured to set parameters for a plurality of voltage waveforms; a signal generator, coupled to the controller, configured to generate the plurality of voltage waveforms; and the working electrode is a gold working electrode, and wherein the gold working electrode and the counter electrode are configured to: deliver another voltage waveform of the plurality of voltage waveforms that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, wherein the controller determines the chloride concentration of the sweat within the sweat chamber based on the electrochemical reaction.
Zevenbergen teaches an analogous system (Abstract, Fig. 1, para. [0045]). Zevenbergen further teaches a controller configured to set parameters for a plurality of voltage waveforms; a signal generator, coupled to the controller, configured to generate the plurality of voltage waveforms (Fig. 1, para. [0019], para. [0042-0043]). Zevenbergen further teaches a sweat sensing and collection unit comprising a gold working electrode, and wherein the gold working electrode and the counter electrode are configured to: deliver another voltage waveform of the plurality of voltage waveforms that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, wherein the controller determines the chloride concentration of the sweat within the sweat chamber based on the electrochemical reaction (para. [0042], “data transmission circuitry …”, para. [0043-0044], “detect a concentration of chloride ions in sweat … voltage different between the two electrodes …”, para. [0051-0052], para. [0060], “first electrodes … gold”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device and chloride sensing unit disclosed by Heikenfeld to additionally include a controller configured to set parameters for a plurality of voltage waveforms; a signal generator, coupled to the controller, configured to generate the plurality of voltage waveforms, a gold working electrode, and wherein the gold working electrode and the counter electrode are configured to: deliver another voltage waveform of the plurality of voltage waveforms that causes chloride ions in the sweat to undergo an electrochemical reaction with gold molecules of the gold working electrode, wherein the controller determines the chloride concentration of the sweat within the sweat chamber based on the electrochemical reaction, as taught by Zevenbergen. This is because Zevenbergen teaches the detection of chloride concentration can be performed using an electrochemical reaction caused by an application of voltage (para. [0043-0044]), and gold electrodes are suitable for use in electrochemistry (para. [0060]) yielding predictable results.
However, modified Heikenfeld does not explicitly disclose the controller determines whether a sufficient volume of sweat is within the sweat chamber, and the voltage waveform is delivered in response to a determination that the sufficient volume of sweat is within the sweat chamber.
Peyser teaches an analogous wearable device for collecting sweat (Abstract, para. [0015]). Peyser further teaches a controller determines whether a sufficient volume of sweat is within the sweat chamber, and the voltage waveform is delivered in response to a determination that the sufficient volume of sweat is within the sweat chamber (para. [0103], para. [0123-0125], para. [0130-0132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to determine whether a sufficient volume of sweat is within the sweat chamber, and the voltage waveform is delivered in response to a determination that the sufficient volume of sweat is within the sweat chamber, as taught by Peyser. This is because Peyser teaches that determining if sweat is within the chamber and delivering a voltage waveform in response to a determination allows for an appropriate amount of sweat to be collected in order to make proper determinations (para. [0130-0132]).
However, modified Heikenfeld does not explicitly disclose the gold working electrode and the counter electrode are configured to: deliver one of the plurality of voltage waveforms therebetween to determine the sufficient volume of sweat is within the sweat chamber based on an impedance measured between the gold working electrode and the counter electrode.
Javey teaches an analogous system (Abstract, Fig. 1) comprising a sweat sensing and collection unit (Fig. 1, para. [0111], para. [0129-0132]). Javey further teaches wherein the gold working electrode and the counter electrode are configured to: deliver one of the plurality of voltage waveforms therebetween to determine the sufficient volume of sweat is within the sweat chamber based on an impedance measured between the gold working electrode and the counter electrode (para. [0080], para. [0112-0113], para. [0129-0130]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Heikenfeld to additionally deliver one of the plurality of voltage waveforms therebetween, to determine the sufficient volume of sweat is within the sweat chamber based on an impedance measured between the gold working electrode and the counter electrode, as taught by Javey. This is because Javey teaches measuring an impedance change is a known technique for detecting if fluid is within a chamber (para. [0160]).
Regarding claim 11, modified Heikenfeld discloses the system of claim 10, further comprising a wireless transmitter configured to transmit the chloride concentration to a mobile device or data center for analysis, the mobile device or the data center configured to generate a notification to the user based on the analysis (Fig. 1, element 150, para. [0044], “wired communication or wireless communication with a reader … smartphone or portable electronic device”).
Regarding claim 12, modified Heikenfeld discloses the system of claim 10, wherein at least a portion of the system is embodied within a wearable device that is configured to be secured to the skin of the user (Fig. 1, Fig. 10, para. [0042-0043], “wearables … patches, bandages …”).
Regarding claim 15, Heikenfeld discloses a method (Abstract, “method capable of collecting a fluid sample …”) comprising:
a chloride sensing unit comprising a working electrode and a counter electrode is located within the chamber (Fig. 10, element 1026, element 1028, para. [0083], “chloride sensors …”),
delivering, by the system, a voltage waveform between the working electrode and the counter electrode within the chamber (Fig. 10, element 1026, element 1028, para. [0040], para. [0083], “chloride sensors …”); and
detecting, by the system, a chloride concentration of the sweat in the chamber (para. [0083], “chloride sensors … determine the degree of concentration occurring”),
wherein information regarding the chloride concentration is used to determine one or more physiological conditions of a user based on the chloride concentration of the sweat in the chamber (para. [0083]).
However, Heikenfeld does not explicitly disclose the chloride sensing unit comprises a gold working electrode, and the detecting is based on signals associated with the electrochemical reaction between the chloride ions and the molecules from the gold working electrode.
Zevenbergen teaches an analogous method including a chloride sensing unit (Abstract, Fig. 1, para. [0045]). Zevenbergen further teaches the chloride sensing unit comprises a gold working electrode, and the detecting is based on signals associated with the electrochemical reaction between the chloride ions and the molecules from the gold working electrode (para. [0043-0044], “detect a concentration of chloride ions in sweat … voltage different between the two electrodes …”, para. [0051-0052], para. [0060], “first electrodes … gold”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Heikenfeld to additionally comprise a gold working electrode, and have the detecting is based on signals associated with the electrochemical reaction between the chloride ions and the molecules from the gold working electrode, as taught by Zevenbergen. This is because Zevenbergen teaches the detection of chloride concentration can be performed using an electrochemical reaction caused by an application of voltage (para. [0043-0044]), gold electrodes are suitable for use in electrochemistry (para. [0060]) yielding predictable results.
However, modified Heikenfeld does not explicitly disclose determining, by a system comprising a processor, whether an amount of sweat fills a chamber of a sweat collection unit, wherein the determining is based on a signal between the electrodes, and delivering a voltage in response to the signal indicating that a sufficient amount of sweat fills the chamber.
Peyser teaches an method of using a wearable device for collecting sweat (Abstract, para. [0015]). Peyser further teaches determining, by a system comprising a processor, whether an amount of sweat fills a chamber of a sweat collection unit, wherein the determining is based on a signal between the electrodes, and delivering a voltage in response to the signal indicating that a sufficient amount of sweat fills the chamber (para. [0103], para. [0123-0125], para. [0130-0132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally determine, by a system comprising a processor, whether an amount of sweat fills a chamber of a sweat collection unit, wherein the determining is based on a signal between the electrodes, and delivering a voltage in response to the signal indicating that a sufficient amount of sweat fills the chamber, as taught by Peyser. This is because Peyser teaches that determining if sweat is within the chamber and delivering a voltage waveform in response to a determination allows for an appropriate amount of sweat to be collected in order to make proper determinations (para. [0130-0132]).
However, modified Heikenfeld does not explicitly disclose the determining is based on an impedance between the gold working electrode and the counter electrode.
Javey teaches an analogous method (Abstract, Fig. 1). Javey further teaches the determining is based on an impedance between the gold working electrode and the counter electrode (para. [0080], para. [0112-0113], para. [0129-0130]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Heikenfeld to additionally determine the amount of sweat based on an impedance between the gold working electrode and the counter electrode, as taught by Javey. This is because Javey teaches measuring an impedance change is a known technique for detecting if fluid is within a chamber (para. [0160]).
Regarding claim 16, modified Heikenfeld discloses the method of claim 15, wherein the impedance is measured between the gold working electrode and the counter electrode (Zevenbergen, para. [0060]; Javey, para. [0080], para. [0112-0113], para. [0129-0130] - further see the rejection of claim 15 regarding the combination of the gold working electrode and the impedance measurement).
Regarding claim 17, modified Heikenfeld discloses the method of claim 16, wherein if the amount of sweat is not sufficient, then the method further comprises: notifying, by the system, the user that sweat is insufficient and to trigger a sweat stimulation unit of the system, wherein the user physically triggers the sweat stimulation unit (Fig. 13A, para. [0029], “sweat stimulation … drugs using iontophoresis … asking the device wearer to enact or increase activities or conditions that cause them to sweat”, para. [0071], “sweat stimulation … iontophoresis capabilities … electrode, and component is an agar gel with pilocarpine …”).
Regarding claim 19, modified Heikenfeld discloses the method of claim 17, further comprising: selecting, by the system, one drug storage reservoir of a plurality of drug storage reservoirs to release a drug from to induce sweat (Fig. 13A, Fig. 13B, Fig. 13C, para. [0029], “positive pole … negative pole …”, para. [0072], “plurality components for sweat stimulation …”, para. [0074], “control, initiate, or stop flow of sweat …”).
Regarding claim 20, modified Heikenfeld discloses the method of claim 15, wherein the chloride concentration is detected once, once a day, once an hour, or once a half hour (para. [0044], “one-time data download).
Regarding claim 21, modified Heikenfeld discloses the method of claim 15, wherein the system is a wearable device (para. [0042], “wearables”).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-12, 15-17, and 19-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the rejection relies upon the newly cited reference Peyser et al. (US 20070027383 A1).
Prior Art Analysis - Maintained
Claims 5-6, 13-14, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art includes the prior art made cited above, and Guitierrez (US 20200214887 A1) (previously cited).
Regarding claims 5-6, Heikenfeld teaches sweat stimulation can be induced using iontophoresis (para. [0029]), specifically with an electrode with an agar gel with pilocarpine or carbachol (para. [0071]). However, one of ordinary skill in the art would not have been motivated in view of the prior art to modify the dermal introduction of a drug using iontophoresis with a drug stored in a repository as a dry drug that is mixed with saline after release from the drug delivery unit and before the iontophoresis, as required by claim 5.
Regarding claims 13-14 and 18, Guitierrez teaches a process of using a first iontophoresis electrode and a second iontophoresis electrode to electrodissolve a gold film to release a drug (Fig. 6B, para. [0061], para. [0068], para. [0079]). However, Guitierrez teaches the process is used to deliver a drug to an eye (para. [0079]), and one of ordinary skill in the art would not have been motivated in view of Guitierrez to modify the agar gel with pilocarpine or carbachol taught by Heikenfeld.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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